Roseman T J, Brown J A, Scothorn W W
J Pharm Sci. 1976 Jan;65(1):22-9. doi: 10.1002/jps.2600650103.
The scanning electron microscope was utilized to explore the internal surface of glass ampuls and vials used in parenteral products. The surface topography of USP Type I borosilicate glass containers was viewed after exposure to "sulfur," ammonium bifluoride, and sulfuric acid treatments. The scanning electron micrographs showed startling differences in the appearance of the surface regions. "Sulfur treatment" of ampuls was associated with a pitting of the surface and the presence of sodium sulfate crystals. The sulfur treatment of vials altered the glass surface in a characteristically different manner. The dissimilarity between the surface appearances was attributed to the method of sulfur treatment. Ampuls exposed to sulfuric acid solutions at room temperature did not show the pitting associated with the sulfur treatment. Scanning electron micrographs of ammonium bifluoride-treated ampuls showed a relief effect, suggesting that the glass was affected by the bifluoride solution but that sufficient stripping of the surface layer did not occur to remove the pits associated with the sulfur treatment. Flakes emanating from the glass were identified with the aid of the electron microprobe. Scanning electron micrographs showed that these vitreous flakes resulted from a delamination of a thin layer of the glass surface. It is concluded that the scanning electron microscope, in conjunction with other analytical techniques, is a valuable tool in assessing the quality of glass used for parenteral products. The techniques studied should be of particular importance to the pharmaceutical industry where efforts are being made to reduce the levels of particulate matter in parenteral dosage forms.
利用扫描电子显微镜探索用于注射用产品的玻璃安瓿和小瓶的内表面。在暴露于“硫磺”、氟化氢铵和硫酸处理后，观察美国药典I型硼硅酸盐玻璃容器的表面形貌。扫描电子显微镜图像显示表面区域的外观存在惊人差异。安瓿的“硫磺处理”与表面麻点和硫酸钠晶体的存在有关。小瓶的硫磺处理以一种明显不同的方式改变了玻璃表面。表面外观的差异归因于硫磺处理方法。在室温下暴露于硫酸溶液的安瓿没有显示出与硫磺处理相关的麻点。氟化氢铵处理过的安瓿的扫描电子显微镜图像显示出一种浮雕效应，这表明玻璃受到了氟化物溶液的影响，但表面层没有被充分剥离以去除与硫磺处理相关的麻点。借助电子微探针识别了从玻璃中散发出来的薄片。扫描电子显微镜图像显示这些玻璃薄片是由玻璃表面薄层的分层产生的。得出的结论是，扫描电子显微镜与其他分析技术相结合，是评估用于注射用产品的玻璃质量的有价值工具。所研究的技术对制药行业尤为重要，因为制药行业正在努力降低注射剂型中的颗粒物质水平。
